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FDA Approval

DEXAMETHASONE 6-Day

CompanyXspire Pharma, Llc (DUNS: 078312042)

Effective Date

January 18, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dexamethasone(1.5 mg in 1 1)

Manufacturing Establishments (1)

Labeler

Xspire Pharma, Llc

DUNS Number

078312042

Products (1)

DEXAMETHASONE 6-Day

NDC Product Code

42195-721

Application Number

ANDA088237

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 18, 2022

Ingredients

DexamethasoneActive

Code: 7S5I7G3JQLClass: ACTIBQuantity: 1.5 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

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